80_FR_68761 80 FR 68547 - Prospective Grant of Exclusive License: Development of Therapeutics To Treat Brain Injury and Neurodegenerative Disease

80 FR 68547 - Prospective Grant of Exclusive License: Development of Therapeutics To Treat Brain Injury and Neurodegenerative Disease

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 214 (November 5, 2015)

Page Range68547-68547
FR Document2015-28245

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7, that the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Astrocyte Pharmaceuticals, Inc., (``Astrocyte''), a company incorporated under the laws of Delaware and having an office in Cambridge, Massachusetts, to practice the following inventions embodied in the following patent applications: US Provisional Patent Appl. No. 60/176,373 entitled, ``Methanocarba cycloalkyl nucleoside analogues,'' filed 14 Jan 2000 [HHS reference E-176-1999/0-US-01]; Intl. Appl. No. PCT/US01/00981, entitled, ``Methanocarba cycloalkyl nucleoside analogues,'' filed 12 Jan 2001 [HHS reference E-176-1999/0-PCT-02]; Australia Patent No. 2001230913, issued 13 Oct 2005 [HHS reference E- 176-1999/0-AU-03]; Canada Patent No. 2.397,366, issued 15 Mar 2011 [HHS reference E-176-1999/0-CA-04]; European Patent Appl. No. 01903043.6 entitled, filed 12 Jan 2001 [HHS Ref No E-176-1999/0-EP-05]; US Patent No. 7,087,589, issued 8 Aug 2006 [HHS reference E-176-1999/0-US-06]; US patent No. 7,790,735, issued 8 Aug 2006 [HHS reference E-176-1999/0-US- 07]; and Great Britain patent No. 1252160, issued 16 Aug 2006 [HHS reference E-176-1999/0-US-08]. The patent rights in these inventions have been assigned to the United States of America. The territories included in this license may be worldwide. The field of use may be related to ``Use of the patent rights in the development and sale of therapeutics for cerebral trauma, stroke, and neurodegenerative disorders.''

Federal Register, Volume 80 Issue 214 (Thursday, November 5, 2015)
[Federal Register Volume 80, Number 214 (Thursday, November 5, 2015)]
[Notices]
[Page 68547]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-28245]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of 
Therapeutics To Treat Brain Injury and Neurodegenerative Disease

AGENCY: National Institute of Diabetes and Digestive and Kidney 
Diseases, National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 
part 404.7, that the National Institute of Diabetes and Digestive and 
Kidney Diseases, National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of an exclusive patent 
license to Astrocyte Pharmaceuticals, Inc., (``Astrocyte''), a company 
incorporated under the laws of Delaware and having an office in 
Cambridge, Massachusetts, to practice the following inventions embodied 
in the following patent applications: US Provisional Patent Appl. No. 
60/176,373 entitled, ``Methanocarba cycloalkyl nucleoside analogues,'' 
filed 14 Jan 2000 [HHS reference E-176-1999/0-US-01]; Intl. Appl. No. 
PCT/US01/00981, entitled, ``Methanocarba cycloalkyl nucleoside 
analogues,'' filed 12 Jan 2001 [HHS reference E-176-1999/0-PCT-02]; 
Australia Patent No. 2001230913, issued 13 Oct 2005 [HHS reference E-
176-1999/0-AU-03]; Canada Patent No. 2.397,366, issued 15 Mar 2011 [HHS 
reference E-176-1999/0-CA-04]; European Patent Appl. No. 01903043.6 
entitled, filed 12 Jan 2001 [HHS Ref No E-176-1999/0-EP-05]; US Patent 
No. 7,087,589, issued 8 Aug 2006 [HHS reference E-176-1999/0-US-06]; US 
patent No. 7,790,735, issued 8 Aug 2006 [HHS reference E-176-1999/0-US-
07]; and Great Britain patent No. 1252160, issued 16 Aug 2006 [HHS 
reference E-176-1999/0-US-08]. The patent rights in these inventions 
have been assigned to the United States of America. The territories 
included in this license may be worldwide. The field of use may be 
related to ``Use of the patent rights in the development and sale of 
therapeutics for cerebral trauma, stroke, and neurodegenerative 
disorders.''

DATES: Only written comments or applications for a license (or both) 
which are received by the Technology Advancement Office of the National 
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) on or 
before November 20, 2015 will be considered.

ADDRESSES: Requests for copies of the patent application, patents, 
inquiries, comments, and other materials relating to the contemplated 
exclusive license should be directed to: Patrick McCue, Ph.D., Senior 
Licensing and Patenting Manager, Technology Advancement Office, The 
National Institute of Diabetes and Digestive and Kidney Diseases, 12A 
South Drive, Bethesda, MD 20892, Telephone: (301) 435-5560; Email: 
patrick.mccue@nih.gov. A signed confidentiality non-disclosure 
agreement will be required to receive copies of any patent applications 
that have not been published by the United States Patent and Trademark 
Office or the World Intellectual Property Organization.

SUPPLEMENTARY INFORMATION: 
    The technology provides novel nucleoside and nucleotide derivatives 
that are agonist or antagonists of P1 and P2 receptors and may be 
useful in the treatment or prevention of various diseases including 
airway diseases, cancer, cardiac arrhythmias, cardiac ischemia, 
epilepsy, and Huntington's Disease.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 
404. The prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the NIDDK 
receives written evidence and argument that establishes that the grant 
of the license would not be consistent with the requirements of 35 
U.S.C. 209 and 37 CFR part 404.
    Properly filed competing applications for a license received by the 
NIDDK in response to this notice will be treated as objections to the 
contemplated license. Comments and objections submitted in response to 
this notice will not be made available for public inspection and, to 
the extent permitted by law, will not be released under the Freedom of 
Information Act, 5 U.S.C. 552.

    Dated: October 30, 2015.
Anna Z. Amar,
Acting Deputy Director, Technology Advancement Office, National 
Institute of Diabetes and Digestive and Kidney Diseases, National 
Institutes of Health.
[FR Doc. 2015-28245 Filed 11-4-15; 8:45 am]
BILLING CODE 4140-01-P



                                                                             Federal Register / Vol. 80, No. 214 / Thursday, November 5, 2015 / Notices                                                 68547

                                                  III. Electronic Access                                  SUMMARY:    This notice, in accordance                States Patent and Trademark Office or
                                                     Persons with access to the Internet                  with 35 U.S.C. 209(c)(1) and 37 CFR                   the World Intellectual Property
                                                  may obtain the document at either                       part 404.7, that the National Institute of            Organization.
                                                  http://www.fda.gov/ScienceResearch/                     Diabetes and Digestive and Kidney
                                                                                                                                                                SUPPLEMENTARY INFORMATION:
                                                  SpecialTopics/RunningClinicalTrials/                    Diseases, National Institutes of Health,
                                                                                                          Department of Health and Human                           The technology provides novel
                                                  ProposedRegulationsand                                                                                        nucleoside and nucleotide derivatives
                                                  DraftGuidances/default.htm, or http://                  Services, is contemplating the grant of
                                                                                                          an exclusive patent license to Astrocyte              that are agonist or antagonists of P1 and
                                                  www.hhs.gov/ohrp/newsroom/                                                                                    P2 receptors and may be useful in the
                                                  index.html, or http://                                  Pharmaceuticals, Inc., (‘‘Astrocyte’’), a
                                                                                                          company incorporated under the laws of                treatment or prevention of various
                                                  www.regulations.gov.                                                                                          diseases including airway diseases,
                                                                                                          Delaware and having an office in
                                                    Dated: October 23, 2015.                              Cambridge, Massachusetts, to practice                 cancer, cardiac arrhythmias, cardiac
                                                  Karen B. DeSalvo,                                       the following inventions embodied in                  ischemia, epilepsy, and Huntington’s
                                                  Acting Assistant Secretary for Health. U.S.             the following patent applications: US                 Disease.
                                                  Department of Health and Human Services.                Provisional Patent Appl. No. 60/176,373                  The prospective exclusive license will
                                                    Dated: October 27, 2015.                              entitled, ‘‘Methanocarba cycloalkyl                   be royalty bearing and will comply with
                                                  Leslie Kux,                                             nucleoside analogues,’’ filed 14 Jan 2000             the terms and conditions of 35 U.S.C.
                                                  Assistant Commissioner for Policy, U.S. Food            [HHS reference E–176–1999/0–US–01];                   209 and 37 CFR part 404. The
                                                  and Drug Administration.                                Intl. Appl. No. PCT/US01/00981,                       prospective exclusive license may be
                                                  [FR Doc. 2015–27986 Filed 11–4–15; 8:45 am]             entitled, ‘‘Methanocarba cycloalkyl                   granted unless within fifteen (15) days
                                                                                                          nucleoside analogues,’’ filed 12 Jan 2001             from the date of this published notice,
                                                  BILLING CODE 4164–01–P
                                                                                                          [HHS reference E–176–1999/0–PCT–02];                  the NIDDK receives written evidence
                                                                                                          Australia Patent No. 2001230913, issued               and argument that establishes that the
                                                  DEPARTMENT OF HEALTH AND                                13 Oct 2005 [HHS reference E–176–                     grant of the license would not be
                                                  HUMAN SERVICES                                          1999/0–AU–03]; Canada Patent No.                      consistent with the requirements of 35
                                                                                                          2.397,366, issued 15 Mar 2011 [HHS                    U.S.C. 209 and 37 CFR part 404.
                                                  National Institutes of Health                           reference E–176–1999/0–CA–04];                           Properly filed competing applications
                                                                                                          European Patent Appl. No. 01903043.6                  for a license received by the NIDDK in
                                                  National Institute on Aging; Amended                    entitled, filed 12 Jan 2001 [HHS Ref No               response to this notice will be treated as
                                                  Notice of Meeting                                       E–176–1999/0–EP–05]; US Patent No.                    objections to the contemplated license.
                                                    Notice is hereby given of a change in                 7,087,589, issued 8 Aug 2006 [HHS                     Comments and objections submitted in
                                                  the meeting of the National Institute on                reference E–176–1999/0–US–06]; US                     response to this notice will not be made
                                                  Aging Special Emphasis Panel,                           patent No. 7,790,735, issued 8 Aug 2006               available for public inspection and, to
                                                  November 12, 2015, 10:00 a.m. to                        [HHS reference E–176–1999/0–US–07];                   the extent permitted by law, will not be
                                                  November 12, 2015, 02:00 p.m.,                          and Great Britain patent No. 1252160,                 released under the Freedom of
                                                  National Institute on Aging, Gateway                    issued 16 Aug 2006 [HHS reference E–                  Information Act, 5 U.S.C. 552.
                                                  Building, 7201 Wisconsin Avenue, Suite                  176–1999/0–US–08]. The patent rights                    Dated: October 30, 2015.
                                                  2C212, Bethesda, MD, 20892 which was                    in these inventions have been assigned                Anna Z. Amar,
                                                  published in the Federal Register on                    to the United States of America. The                  Acting Deputy Director, Technology
                                                  October 19, 2015, 80 FR 63236.                          territories included in this license may              Advancement Office, National Institute of
                                                    The meeting notice is amended to                      be worldwide. The field of use may be                 Diabetes and Digestive and Kidney Diseases,
                                                  change the date of the meeting from                     related to ‘‘Use of the patent rights in              National Institutes of Health.
                                                  November 12, 2015 to November 24,                       the development and sale of                           [FR Doc. 2015–28245 Filed 11–4–15; 8:45 am]
                                                  2015. The meeting is closed to the                      therapeutics for cerebral trauma, stroke,             BILLING CODE 4140–01–P
                                                  public.                                                 and neurodegenerative disorders.’’
                                                    Dated: October 30, 2015.                              DATES: Only written comments or
                                                                                                          applications for a license (or both)                  DEPARTMENT OF HEALTH AND
                                                  Melanie J. Gray,
                                                                                                          which are received by the Technology                  HUMAN SERVICES
                                                  Program Analyst, Office of Federal Advisory
                                                  Committee Policy.                                       Advancement Office of the National
                                                                                                          Institute of Diabetes and Digestive and               National Institutes of Health
                                                  [FR Doc. 2015–28230 Filed 11–4–15; 8:45 am]
                                                                                                          Kidney Diseases (NIDDK) on or before                  National Cancer Institute; Notice of
                                                  BILLING CODE 4140–01–P
                                                                                                          November 20, 2015 will be considered.                 Closed Meetings
                                                                                                          ADDRESSES: Requests for copies of the
                                                  DEPARTMENT OF HEALTH AND                                patent application, patents, inquiries,                 Pursuant to section 10(d) of the
                                                  HUMAN SERVICES                                          comments, and other materials relating                Federal Advisory Committee Act, as
                                                                                                          to the contemplated exclusive license                 amended (5 U.S.C. App.), notice is
                                                  National Institutes of Health                           should be directed to: Patrick McCue,                 hereby given of the following meetings.
                                                                                                          Ph.D., Senior Licensing and Patenting                   The meetings will be closed to the
                                                  Prospective Grant of Exclusive                          Manager, Technology Advancement                       public in accordance with the
                                                  License: Development of Therapeutics                    Office, The National Institute of                     provisions set forth in sections
                                                  To Treat Brain Injury and                               Diabetes and Digestive and Kidney                     552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                  Neurodegenerative Disease                               Diseases, 12A South Drive, Bethesda,                  as amended. The grant applications and
                                                  AGENCY: National Institute of Diabetes                  MD 20892, Telephone: (301) 435–5560;                  the discussions could disclose
                                                  and Digestive and Kidney Diseases,                      Email: patrick.mccue@nih.gov. A signed                confidential trade secrets or commercial
                                                  National Institutes of Health, Public                   confidentiality non-disclosure                        property such as patentable material,
                                                  Health Service, DHHS.                                   agreement will be required to receive                 and personal information concerning
                                                                                                          copies of any patent applications that                individuals associated with the grant
                                                  ACTION: Notice.
                                                                                                          have not been published by the United                 applications, the disclosure of which


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Document Created: 2015-12-14 15:02:39
Document Modified: 2015-12-14 15:02:39
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesOnly written comments or applications for a license (or both) which are received by the Technology Advancement Office of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) on or before November 20, 2015 will be considered.
FR Citation80 FR 68547 

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